The session titled "Medical Device Valuation in the Age of Health Reform" will begin at 2:00 p.m. in the Meridian Ballrooms 3 and 4 of The Commons Hotel in Minneapolis.

The University of Minnesota's Medical Devices Center (part of the Institute for Engineering in Medicine), the College of Science and Engineering, and the Academic Health Center present the 12th Annual Design of Medical Devices Conference. The world's largest medical device conference will be held at The Commons Hotel (formerly University Hotel Minneapolis), located at 615 Washington Ave. SE, Minneapolis, Minnesota 55414, adjacent to the University of Minnesota campus.

Presentation Abstract:

In December of 2010, the developer of a novel treatment for congestive heart failure, Acorn Cardiovascular, shut its doors after failing to receive FDA approval. The closure of the company marked an end to a battle with the regulatory agency that lasted nearly a decade. In October of 2011, venture capitalists and lobbyists for the medical device industry called for reforms to the FDA and its process for review of medical devices in time for the re-authorization of the Medical Device User Fee and Modernization Act. [1] Acorn Cardiovascular was cited as an example of the devastating impacts the FDA's unpredictability and regulatory barriers could have on a company and ultimately, the economy. [2]

Though the FDA has become the visible scapegoat for the failure of medical device startups, any number of miscalculations or missteps can have an irreparable effect on a startup. The underlying cause for failure of a medical device startup is far more complicated than simply assigning blame to the FDA or to management. The medical device industry operates in a dynamic environment in which market and regulatory constraints are intricately woven with management's execution rendering it difficult for startups to navigate. Medical device startups are not immune to the obstacles that other venture-backed companies face in developing a new product, such as changes in market conditions, the economic environment, and the need to generate revenue as quickly as possible. But there are forces that are unique to this field that elevate the risks and magnify the costs of failure for new entrants. Some of these are external to the company; some are internal.

A thorough understanding of these external and internal forces is necessary to detangle the speculated from the underlying cause of a medical device startup's failure.